Quality Business Partner, Pre-clinical Research

Overview

As a Quality Business Partner within R&D, you will advise on quality strategies and quality by design across Research. You’ll partner with pre-clinical and therapy-area teams to embed a strong quality culture and mitigate risk. Your work will influence processes, KPI/ KQI metrics, and cross-functional QMS activities, ensuring swift communication of quality issues. This role supports due diligence, risk management and continuous improvement, contributing to GSK’s quality-driven R&D aspirations.

Responsibilities

• Act as Quality Partner for R&D Research and define quality strategy activities for the area
• Collaborate with Risk & Issue Management and Research to deliver QBD (quality by design) initiatives
• Share learnings to simplify processes and propagate best practices
• Provide expert quality information to business teams and drive continuous improvement
• Review and support cross-functional QMS activities and procedures
• Foster a quality-first culture across GSK and third parties
• Support due diligence and M&A activities
• Define KPI, KQI, and metrics needs with R&D Data Analytics and stakeholders
• Ensure rapid communication of quality issues and risks to leaders
• Assist with root cause analysis, CAPA, and investigations of serious issues
• Participate in special projects and cross-functional workstreams determined by R&D Quality & Risk Management LT

Key requirements

• Bachelor’s degree or equivalent in scientific or quality-related field; experience in drug development, regulatory compliance or quality management
• Expert knowledge of non-clinical research practices, GLP/GCP or Animal Welfare regulatory requirements
• Diverse stakeholder management with influencing ability
• Knowledge of quality by design and risk management principles
• Expert working knowledge of continuous improvement tools

• Effective communication and negotiation
• Strong collaboration across diverse teams
• Analytical mindset and problem-solving abilities
• Quality by Design
• Risk management
• QMS integration and CAPA processes

…